Germany Trade and Invest (GTAI

Major push for digital health

In 2021, digital health was another growth topic for many companies in the German medical technology sector. With the Digital Care Act into effect since January 2020, digital apps can be regularly prescribed and receive approval by the Federal Institute for Drugs and Medical Devices (BfArM) as Digital Health Appliacation (DiGA) which results into official reimbursement by the statutory health insurance companies. With this, Germany’s DiGA Fast Track process has created a new model for enabling more rapid market access for digital health applications into German standard care. Medical apps classified as class I and IIa medical devices can apply for fast-track market access and, after a successful completion of a maximum three-month assessment period, can be listed in the DiGA, Digital Health Applications directory for reimbursable digital health apps. For the moment, the DiGA Fast Track Process focuses on low to medium risk medical devices of classes I and IIa. However, because many apps will be upgraded to higher risk classes under the stricter medical devices regime of the EU Medical Device Regulation (Regulation (EU) 2017/745) which has just recently become applicable, it is likely that the DiGA Fast Track Process will need to be adapted to include higher risk DiGAs in the near future. In fact, other countries such as France already announced plans to replicate the German process, and the regulation is being considered as a model for further developments at the European level. The harmonisation of healthcare systems regarding digitalisation and digital health, in particular with comparable requirements for interoperability, could drive the development of a more aligned European healthcare sector, many experts assume. For this reason, Germany is expected to see an uptick in DiGA Fast Track applications in 2022, and developers of apps are well advised to consider the DiGA Fast Track Process for their digital health apps.

Ongoing challenge with MDR

The new EU Medical Device Regulation (MDR), for which the end of the transition period was scheduled for May 2021, is still one of the major topics widely discussed in the German medical technology industry. Most experts assume that the years 2022 to 2024 will be the most critical periods to watch. By then, a huge number of expiring MDD certificates will appear which will lead to massive capacity problems within the notifed bodies. As total numbers of these bodies is still low and demand for experienced regulatory affairs experts is higher than existing personel available, many foresee considerable bottlenecks for the industry to deal with in the upcoming years. However, German policy makers already started to massively fund new supporting infrastructures, particularly in Southern Germany, accompanied by funding programs aimed at helping companies to find targeted or joint solutions. If and how product portfolios are cut down, is still an open question, even among experts. Hope exists, that adapted regulations could at least apply for products in niche markets such as for children or rare diseases, and that for standard products already used safely for decades in the market, lower overall documentation will be needed in the long-run.